Table 4.

Health literacy criteria addressed by Institutional Review Board websites

Health Literacy Criteria Provided	Sites N	Example Text from IRB Websites
Reading Level
Guidance on grade reading level	8	Consent documents should be written at an 8th grade reading level or less for the average adult population.
Content
Guidance on the purpose of the document	8	Start with an introductory sentence describing the primary purpose of the research as stated in the protocol: State what the study is designed to discover or establish.
Literacy Demand
Active, direct writing style	5	Whenever possible use active voice and break up the text into short straightforward sections.
Personal, conversational writing style	3	Use words familiar to the audience. Write consent form in conversational style, as if you were speaking to the reader.
Common, explicit words that are clear and specific in meaning	7	Lay language should be used. Avoid technical or professional language used in grant submissions or with peers.
Simple sentences	8	Use short, simple and direct sentences. Use short sentences and limit paragraphs to one main idea. Average sentence length of 15 words or less.
Explain or clarify difficult words	7	Define terms which might not be familiar to the average person the first time they are mentioned Avoid research and medical jargon whenever possible. If you must use a complicated term, define it in plain language and provide an example, an analogy, or a visual aid. Scientific, technical, and medical terms must be defined or explained in lay terms.
Numeracy
Use of numbers or numerical terms	4	Define terms or use lay terms. Include definitions for specific research design features (e.g., double-blind, randomization, placebo-controlled, dose escalation) if these will help participants understand the study.
Terms should be defined	6	When describing randomization for 2 groups use, “like the flip of a coin,” for more than 2 groups, use “like drawing numbers from a hat.”
Graphics
Use of charts, graphs, or tables	5	Use photos, graphics or tables if they will help clarify procedures. Use diagrams as helpful additions to narrative.
Layout
General layout and organization	5	Leave a 1-inch margin around the entire document. Use of subheadings, bulleted lists, tables, flow charts, etc. to improve communication and readability.
Adequate white space	2	Layout balances white space with words and graphics.
Visual cueing devices	3	Underline, bold, or boxes (rather than all caps or italics) to give emphasis.
Size of font	6	12 point at least, and consider larger given audience. Easy to read.
Type of font	3	Use black Arial or similar font, preferably 12-point size, or larger when appropriate for the study population.
Use of headings	4	Titles, subtitles, and other headers help to clarify organization of text. Section headings should be in question format.